Cannabidiol and CES1 Interactions in Healthy Subjects

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT04603391
Collaborator
State of Florida Consortium for Medical Marijuana Clinical Outcomes Research (Other)
12
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10.2
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Study Details

Study Description

Brief Summary

The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects

Condition or Disease Intervention/Treatment Phase
  • Drug: di-Methylphenidate plus Cannabidiol
  • Drug: di-Methylphenidate plus Cannabidiol Placebo solution
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
An open-label, randomized crossover design is proposed wherein healthy volunteer subjects (n=12) would receive a single dose of immediate-release dl-methylphenidate (Ritalin®) concomitantly with orally administered CBD (Epidiolex®) solution or an equal volume of Epidiolex® placebo solution (i.e vehicle with no CBD) which have been dosed to plasma steady-state conditions.An open-label, randomized crossover design is proposed wherein healthy volunteer subjects (n=12) would receive a single dose of immediate-release dl-methylphenidate (Ritalin®) concomitantly with orally administered CBD (Epidiolex®) solution or an equal volume of Epidiolex® placebo solution (i.e vehicle with no CBD) which have been dosed to plasma steady-state conditions.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Assessment of the Drug Interaction Potential Between Oral Cannabidiol (Epidiolex®) and the CES1 Substrate Methylphenidate in Healthy Volunteers
Actual Study Start Date :
Feb 25, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exposure A

Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) CBD 750 mg (administered as 7.5 ml of Epidiolex® solution [100 mg/ml] of CBD)

Drug: di-Methylphenidate plus Cannabidiol
Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) plus CBD 750 mg (administered as 7.5 ml of Epidiolex® solution [100 mg/ml] of CBD)
Other Names:
  • Ritalin®
  • Epidiolex®
  • Active Comparator: Exposure B

    Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) 7.5 ml of Epidiolex® placebo solution containing no CBD.

    Drug: di-Methylphenidate plus Cannabidiol Placebo solution
    Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) 7.5 ml of Epidiolex® placebo solution containing no CBD.
    Other Names:
  • Ritalin®
  • Epidiolex®
  • Outcome Measures

    Primary Outcome Measures

    1. Differences in the geometric mean ratios (GMR) of the pharmacokinetic parameters will be compared between the two exposure conditions; i.e. methylphenidate + CBD vs methylphenidate + placebo. [8 hours for each exposure condition for pharmacokinetic assessments]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Signed Informed Consent

    • Age: 21-45 years

    • Gender: males and females (50:50)

    • Race or ethnicity: no restrictions

    • Body Mass Index (BMI) between 18.5 to 28 kg/m2 (inclusive)

    • Satisfactory completion of the screening medical history, physical exam, and laboratory evaluations.

    • Females of child-bearing potential must have a negative urine pregnancy test prior to enrollment and avoid pregnancy during study participation.

    • With the exception of oral contraceptives, subjects must not be taking prescription or OTC medication for the duration of study participation

    • Subjects must have no ongoing use of any botanical/nutritional supplement, vitamin, or energy drink for the duration of study participation

    Exclusion Criteria:
    • The presence of a known allergy, hypersensitivity, or adverse reaction to CBD or cannabis, or sesame seed oil

    • The presence of a known allergy, hypersensitivity, or adverse reaction to methylphenidate or dexmethylphenidate (Focalin®)

    • A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease will render subjects ineligible for the study.

    • The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion including;

    1. Gastric bezoar

    2. Swallowing disorders

    3. Strictures

    4. Fistulas

    5. GI obstruction

    6. Severe dsyphasgia

    7. Crohn's disease

    8. Diverticulitis

    9. A positive urine pregnancy test.

    10. A positive Urine Drug Screen

    11. Any concomitant prescription medication, OTC medication, herbal or other dietary supplement or vitamins during the study period.

    All subjects must be medication-free from 7 Days before initiation of the first active study day, through the duration of the study. This exclusion the use of vitamins, herbal preparations and OTC supplements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida
    • State of Florida Consortium for Medical Marijuana Clinical Outcomes Research

    Investigators

    • Principal Investigator: John Markowitz, Pharm.D, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04603391
    Other Study ID Numbers:
    • IRB202002547-A
    • OCR39758
    First Posted:
    Oct 26, 2020
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022